Documentation Chemist

Description

Position Summary: A professional responsible for documentation, tracking, and control of elements within the quality management system in the pharmaceutical industry. Key Highlights: 1. Essential experience in pharmaceutical documentation 2. Control of quality management system and GMP 3. Review of files for release of finished product Required Documentation Chemist: Experience in documentation within the pharmaceutical industry. Key responsibilities: Track and control deviation reports, change controls, complaints, non-conformities, returns, out-of-specification results, CAPAs, and risk analyses. Participate in the onboarding training program for new personnel, including GMP training. Maintain original documents properly archived and ensure control over documentation related to quality management system elements. Enforce strict control over controlled and uncontrolled copies. Assign procedure codes, forms, logs, programs, and other documentation generated in each department. Track and safeguard mock recalls and product withdrawals, as well as internal and external audits. Report to the Quality Assurance Coordinator regarding needs, resources, and actions required to mitigate quality management system deviations. Review manufacturing and packaging files for release of finished product. Prepare RAPs and schedules for review with responsible personnel from information-providing departments to maintain such documentation. Requirements: Bachelor’s degree in Pharmaceutical Chemistry and Biology, Pharmacy, Chemistry, Biology, Biotechnology, or a related field. Minimum 2 years of experience in a pharmaceutical microbiology laboratory. Knowledge of NOM-059-SSA1-current, technical documentation systems in the pharmaceutical industry, procedure development, document administration, writing-grammar, and GMP. Flexible working hours. Desired Competencies: Attention to detail; organizational and documentary discipline; teamwork and communication; responsibility and professional ethics. We Offer: Competitive salary based on experience. Statutory benefits and above-standard benefits. Salary: $15,000.00 - $17,000.00 per month Work Location: On-site employment